the telehealth question that gets asked weekly, answered properly
the telehealth question that gets asked weekly, answered properly. It is the sort of thing everyone half-believes and nobody writes down.
Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.
The shortage list is the legal hinge: the permissions that allow certain compounding to happen at scale are tied to a drug’s shortage status, which changes.
A beyond-use date derived from published stability data means something different from one assigned by default rule. Asking which is a fair question and the answer is usually available.
If two or three other people have done the same thing we might actually learn something. Alone it is an anecdote.
best — the order this archive was captured in
Did they name the facility?
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board. Different mechanisms.
Was there potency testing on the finished preparation, or only on the starting material?
Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.
do not assume the concentration matches the branded product
shortage status changes and the whole arrangement changes with it
Correcting my own comment: the shortage status changed in the interim, so the arrangement I described no longer applies.
Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.
the API source is the question nobody asks and everybody should
Not convinced. You are comparing a compounded concentration with a branded one and assuming they match.
compounded is not generic, there is no equivalence claim
compounded is not generic, there is no equivalence claim
Adding one thing — ask for the facility name. Most will give it, and the ones that will not have answered you.
Paid noticeably more at one clinic than another for what turned out to be the same facility behind both.
Disagree — a 503B being registered does not make its preparations equivalent to an approved product. Different regulatory category entirely.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.
Switched between two compounded preparations and the concentration on the label was different.
This is the distinction the whole board runs on. Everything else follows from it.
This is the distinction the whole board runs on.
Agreed — and the follow-up question is what the beyond-use date is based on.
Removed the staff name. Facilities and clinics can be named here; individuals cannot.
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.
Asked for potency testing on the finished preparation. They had it. I had assumed they would not.
I would not read the price difference as a quality signal. Most of it is the consultation model, not the vial.
Agreed on potency testing of the finished preparation. That is a different question from the purity of the starting material.
- 1Concentration on the compounded vial was different from what I had been…11 comments in this branch · started by u/clara_danquah